Pharmaceutical Drug Litigation Updates

EU agency to review safety of newer contraceptive pills | Reuters

Quoted from http://www.reuters.com/article/2013/01/28/us-contraceptives-europe-idUSBRE90R0QM20130128

EU agency to review safety of newer contraceptive pills

LONDON | Mon Jan 28, 2013 12:11pm EST

LONDON (Reuters) - The European Medicines Agency is to review the safety of third and fourth-generation combined oral contraceptives to decide if there is a need to restrict their use.

Monday's move followed a request by France, where authorities have already taken steps to reduce use of the drugs in favor of second-generation birth control pills.

The newer pills, which include Bayer's Meliane or Yasmin, have proved popular because they reduce side effects seen with earlier versions, such as weight gain and acne.

But France wants the European Union regulator to restrict their use because of concerns they carry a higher risk of dangerous blood clots.

While all oral contraceptives are associated with some danger of blood clots, a number of studies suggest the most recent third- and fourth-generation pills carry a higher risk than their predecessors.

[Article continues at original source]

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Some Newer Contraceptive Methods Such As NuvaRing And YAZ / Yasmin Are Under Increasing Scrutiny Over In Europe

France will ask EU to curb use of newer birth control pills

EU agency sees no new risks with combined contraceptives

Quoted from http://www.reuters.com/article/2013/01/11/us-contraceptives-europe-regulator-idUSBRE90A09N20130111

EU agency sees no new risks with combined contraceptive

LONDON | Fri Jan 11, 2013 3:59am EST

LONDON (Reuters) - European drug regulators said on Friday there was no reason for women to stop using combined contraceptives like Bayer's Meliane or Yasmin pills since there was no new evidence pointing to safety risks.

The move comes after French health regulators said last week they were considering limiting use of some birth control pills after a woman sued the German drugmaker over alleged side-effects.

In a statement responding to reports about the so-called "third-generation" contraceptive pills and blood clots known as venous thromboembolisms, the European Medicines Agency (EMA) said it was already well known that the pills "carry a very rare risk of blood clots".

It said that risk differs between types of combined contraceptives.

"These products are constantly and rigorously kept under close monitoring. There is currently no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today," the agency said. "There is no reason for any woman to stop using her contraception."

EMA says the risk of a blood clot is twice as high for women using third and fourth-generation pills than for those using earlier versions, although it remains low. The risk of a stroke is the same.

[Article continues at original source]

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Some Newer Contraceptive Methods Such As NuvaRing And YAZ / Yasmin Are Under Increasing Scrutiny Over In Europe

France will ask EU to curb use of newer birth control pills

Swiss health insurer makes claim against Bayer over Yasmin pill

France will ask EU to curb use of newer birth control pills

Quoted from http://www.reuters.com/article/2013/01/11/france-contraception-eu-idUSL5E9CB6UE20130111

France will ask EU to curb use of newer birth control pills

By Elena Berton

PARIS | Fri Jan 11, 2013 10:09am EST

PARIS Jan 11 (Reuters) - French health authorities will ask the European Union to restrict the use of newer types of contraceptive pills over concerns they might carry health risks.

France's health minister Marisol Touraine said on Friday the newer pills, which have caught on because they reduce side effects from earlier versions such as weight gain and acne, should only be prescribed by specialist doctors to women who cannot use other types of contraception.

Dominique Maraninchi, head of France's health regulator, said at the same news conference: "We will ask Europe not to suspend the pills but to modify prescription guidelines."

While all oral contraceptives are associated with a risk of blood clots, a number of studies suggest the most recent third and fourth-generation pills carry a higher risk than their predecessors.

[Article continues at original source]

Related articles

Some Newer Contraceptive Methods Such As NuvaRing And YAZ / Yasmin Are Under Increasing Scrutiny Over In Europe

Swiss health insurer makes claim against Bayer over Yasmin pill

November 2012 Litigation And Settlement Update: YAZ, Yasmin, Ocella, And Gianvi Lawsuits

Birth Control That Uses Combined Hormones Raises Heart Risk: Study

Quoted from http://health.msn.com/womens-health/birth-control-that-uses-combined-hormones-raises-heart-risk-study

Birth Control That Uses Combined Hormones Raises Heart Risk: Study

Overall odds of heart attack and stroke, however, are still low

By Maureen Salamon
HealthDay Reporter

WEDNESDAY, June 13 (HealthDay News) -- Sweeping new research comparing various forms of hormonal contraception -- including birth control pills, vaginal rings and skin patches -- suggests that the risk for heart attacks and strokes is twice as high among users of combined estrogen-progestin versions.

These include brands such as Yasmin and Yaz pills, the NuvaRing vaginal ring and Ortho Evra patches. The overall odds of suffering such debilitating effects, however, are still quite low.

Analyzing 15 years of observational data from more than 1.6 million women aged 15 to 49, Danish scientists found that those taking low-dose estrogen birth control pills combined with various progestins suffered heart attacks and strokes between 1.5 and 2 times more often than women not using hormonal contraception. The risks were between 2.5 and 3 times higher among users of vaginal rings and transdermal patches compared to non-users.

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Blood Clot Risk Linked to Some Non-Pill Contraceptives

Quoted from http://health.msn.com/womens-health/blood-clot-risk-linked-to-some-non-pill-contraceptives

Blood Clot Risk Linked to Some Non-Pill Contraceptives

Women using hormone-releasing skin patches, implants, vaginal rings were more likely to develop clots, study finds

By Steven Reinberg, HealthDay Reporter

THURSDAY, May 10 (HealthDay News) -- Some women using hormonal contraceptives other than birth control pills may have an increased risk for serious blood clots, Danish researchers report.

These alternate hormone-releasing birth control methods include skin patches, implants and vaginal rings. To reduce the risk, women who use these should consider switching to the pill, the researchers said.

Deep vein thrombosis is a kind of clot that typically originates in the legs and can travel to the lungs, where it becomes an often deadly pulmonary embolism. Both types of clots combined are called venous thrombosis, according to the study. Symptoms include leg pain, chest pain or sudden shortness of breath.

"The transdermal patch and vaginal ring confer at least a sixfold increased risk of venous thrombosis as combined pills with desogestrel or drospirenone, a risk which is about twice the risk among women using second-generation pills with levonorgestrel," said lead researcher Dr. Ojvind Lidegaard, a professor of obstetrics and gynecology at the University of Copenhagen.

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Birth Control Health Risks - Is the NuvaRing Dangerous?

Quoted from http://www.marieclaire.com/health-fitness/news/birth-control-safety

Is Your Birth Control as Safe as You Think?

Since NuvaRing hit the market, more than 700 women have filed lawsuits, claiming it has caused potentially life-threatening blood clots. The battle may change the way millions of women prevent pregnancy.

By Laura Beil

May 24, 2011

 

Christen Childs woke up on September 12, 2009, in the pitch dark of early morning with what she thought was a pulled muscle in her leg. She reached down to massage the cramp, trying to fathom how her left calf could be so achingly sore when she hadn't made it to the gym in weeks. This was a Saturday — by Monday, her leg was swollen and hot, and when she tried to stand, jolts of pain shot up to her spine. She consulted her brother-in-law, a doctor, and he told her to go to the ER immediately. He suspected what an ultrasound would confirm: Childs, 26, had a blood clot in her leg — left untreated, it could kill her. "When the doctor diagnosed me, I started crying," she says. "I was stunned by how close I had come to dying."

Death would come closer still. Later that day, the clot broke apart and traveled to her lungs. Straining to breathe, she remained bedridden in the intensive-care unit as blood thinners were injected into her stomach four times a day for six days. By the following weekend, she was released, instructed to return weekly for hematology checks to make sure new clots hadn't formed. Meanwhile, her doctors ran a battery of tests to figure out what exactly went wrong. After all, Childs didn't have any of the risk factors associated with blood clots: She didn't smoke, wasn't overweight, and had no family history of clots. After six months on blood thinners, Childs was finally back to her old self, with one exception: Her doctors wouldn't let her go back on NuvaRing, her birth control, which they determined was the likely culprit behind her near-fatal illness.

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Orleans Parish woman sues manufacturer of NuvaRing after developing blood clot

Quoted from http://www.louisianarecord.com/news/228403-orleans-parish-woman-sues-manufacturer-of-nuvaring-after-developing-blood-clot

Orleans Parish woman sues manufacturer of NuvaRing after developing blood clot

7/23/2010 12:47 PM By Michelle Massey 

NEW ORLEANS-Jenny Lorusso has filed suit against the manufacturers of the birth control product NuvaRing, alleging the product caused her to suffer a blood clot within a vein.

Lorusso filed suit against Organon Pharmaceuticals USA, Organon International and Schering-Plough Corp. on July 16 in federal court in New Orleans.

She claims she was prescribed NuvaRing in January 2005 and suffered a venous thromboembolism after she began using the drug. Lorusso says it was not until August 2009 that she became aware of the risks associated with NuvaRing through an advertisement.

Lorusso says the drug has a higher risk of thrombotic events as compared to the birth control pill.

The defendants are accused of wrongful conduct including the design, manufacture, distribution, testing, labeling, and failure to warn; failure to warn properly of harmful side effects; warranting and sale of the contraceptive, NuvaRing.

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Lawsuit Claims NuvaRing Caused Deadly Clot

Quoted from http://www.wctv.tv/home/headlines/98285404.html

Lawsuit Claims NuvaRing Caused Deadly Clot Omaha Woman's Estate is Suing Makers of the Contraceptive; Ann Tompkins, 43, Died in 2009 Posted: 8:47 PM Jul 12, 2010 Reporter: AP

(AP) The estate of an Omaha woman who died while using the NuvaRing contraceptive is suing its makers, claiming the device caused a deadly blood clot.

The lawsuit filed Monday in U.S. District Court in Omaha says 43-year-old Ann Tompkins of Omaha died in February 2009, about five months after she began using NuvaRing.

The lawsuit seeks damages from various pharmaceutical companies that currently or at one time manufactured and sold the contraceptive, including Merck & Co., which last year acquired former maker Schering-Plough. Also named are Dutch biopharmaceutical Organon BioSciences NV, its U.S. divisions and its parent company Akzo Nobel NV, all bought by Schering-Plough in 2007.

The lawsuit, believed to be the first filed out of Nebraska targeting NuvaRing, does not list the amount in damages being sought, but asks for actual damages related to such things as funeral costs and lost wages, as well as wrongful death and punitive damages.

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Thrombosis Risk with OCs Depends on Progestogen

Quoted from http://www.medpagetoday.com/OBGYN/GeneralOBGYN/15525

Thrombosis Risk with OCs Depends on Progestogen

By Kristina Fiore, Staff Writer, MedPage Today Published: August 13, 2009 ReviewedbyZalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine.

The risk of venous thrombosis from oral contraceptives is associated with both the estrogen dose and the type of progestogen used, two new studies show. Both found that levonorgestrel carried the lowest risk of thrombosis among all the progestogens. "Our results clearly show that the safest option with regard to the risk of venous thrombosis is an oral contraceptive containing levonorgestrel combined with a low dose of estrogen," wrote Astrid van Hylckama Vlieg, MD, of Leiden University Medical Center, and colleagues on the Dutch study. The study was published online in BMJ along with another by Ojvind Lidegaard, MD, of the Gynecological Clinic in Rigshospitalet in Copenhagen, that produced similar findings. Action Points Explain that two studies in BMJ found that risk of venous thrombosis was associated with both estrogen dose and type of progestogen used in oral contraceptives. Note that levonorgestrel was associated with the lowest risk of venous thrombosis among all the progestogens in both studies. Several large studies have already confirmed a two- to six-fold increased risk of venous thrombosis associated with oral contraceptive use. Estrogen doses have since been lowered, but it is still unclear which oral contraceptive is safest in this regard. [Article continues at original source]